News & Research

Spironolactone has been shown to be a tumorigen in chronic
toxicity studies in rats (see PRECAUTIONS).
Spironolactone and hydrochlorothiazide should be used only in those conditions
described under INDICATIONS AND USAGE. Unnecessary use of this drug should be
avoided.

Fixed-dose combination drugs are not indicated for initial therapy of edema
or hypertension. Edema or hypertension requires therapy titrated to the
individual patient. If the fixed combination represents the dosage so
determined, its use may be more convenient in patient management. The treatment
of hypertension and edema is not static but must be reevaluated as conditions in
each patient warrant.

SUMMARY

Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of
spironolactone, USP and 25 mg of hydrochlorothiazide, USP.

Spironolactone has been shown to be a tumorigen in chronic
toxicity studies in rats (see PRECAUTIONS section).
Spironolactone and hydrochlorothiazide tablets should be used only in those
conditions described below. Unnecessary use of this drug should be avoided.

Spironolactone and Hydrochlorothiazide Tablets are Indicated for:

PRECAUTIONS: Pregnancy). Dependent edema in pregnancy,
resulting from restriction of venous return by the expanded uterus, is properly
treated through elevation of the lower extremities and use of support hose; use
of diuretics to lower intravascular volume in this case is unsupported and
unnecessary. There is hypervolemia during normal pregnancy which is not harmful
to either the fetus or the mother (in the absence of cardiovascular disease),
but which is associated with edema, including generalized edema, in the majority
of pregnant women. If this edema produces discomfort, increased recumbency will
often provide relief. In rare instances, this edema may cause extreme discomfort
which is not relieved by rest. In these cases, a short course of diuretics may
provide relief and may be appropriate.

Spironolactone versus eplerenone for the treatment of idiopathic hyperaldosteronism. [2008.03]The aim of this prospective, randomised, open-label, blinded-end point study was to compare the efficacy and safety of eplerenone versus spironolactone in patients with bilateral idiopathic hyperaldosteronism (IHA). After a 2-week washout period, 34 patients with IHA were assigned to receive either spironolactone 25 mg b.i.d...

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study [Not yet recruiting]
The purpose of this study is to find out if spironolactone added to ambrisentan for
Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find
out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart
pumps every minute), right ventricle function and quality of life.